Teva and Active Biotech put laquinimod into Phase III

Israel’s Teva Pharmaceutical Industries says that it will begin late-stage studies on the novel multiple sclerosis candidate laquinimod, along with its Swedish partner Active Biotech.

The firms are to begin two Phase III clinical trials this year, taking place in the USA, Europe and other locations, following the successful conclusion of a second Phase II study of laquinimod, a novel once-daily, orally administered immunomodulatory compound for the treatment of relapsing multiple sclerosis.

Results from the 36-week, randomised, double-blind, placebo-controlled Phase IIb trial demonstrated that an oral 0.6mg dose of laquinimod given daily significantly reduced magnetic resonance imaging-monitored disease activity by 40% in MS patients and was well tolerated. A previous 24-week Phase IIa trial conducted by Active Biotech, which developed the drug and licensed it to Teva in June 2004, revealed that oral 0.3mg laquinimod given daily was well tolerated and reduced the formation of active lesions.

Teva is best-known as the world’s biggest generics manufacturer but the news on laquinimod is an example of Teva’s desire to expand its brand name franchise. This is led by its MS treatment Copaxone (glatiramer acetate), which had first-quarter sales of $401 million, an increase of 22%, out of total group turnover of $2.08 billion.

Approval for Copaxone one-month syringe

Teva will be hoping that that figure will rise further still, especially since the firm announced, along with partner Sanofi-Aventis, that their application for up-to-one-month room temperature storage of a Copaxone pre-filled syringe has been approved by the US Food and Drug Administration and in Europe under the Mutual Recognition Procedure. Prior to this approval, it could only be stored for up to seven days.

All this good news for Teva was compounded by an upgrade by Credit Suisse from ‘neutral’ to ‘outperform.’ The analysts said that new growth drivers for the company would include generic versions of Purdue Pharma's Oxycontin (oxycodone), Merck & Co’s Fosamax (alendronate) and Novartis’ Lotrel (almodipine/benazepril), adding that Teva should be a main beneficiary of any change to the law regarding biogenerics in the USA.